SBIR-STTR Award

Second Manhood: a Multimedia Intervention for Male Sexual Problems After Cancer
Award last edited on: 4/10/19

Sponsored Program
STTR
Awarding Agency
NIH : NCI
Total Award Amount
$2,258,684
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Paul Martinetti

Company Information

Digital Science Technologies LLC (AKA: DST)

98 Dispatch Drive
Washington Crossing, PA 18977
   (215) 359-8047
   paul@digscitech.com
   www.digitalsciencetechnologies.com

Research Institution

University of Texas - Houston

Phase I

Contract Number: 1R42CA139822-01A1
Start Date: 9/28/09    Completed: 8/31/10
Phase I year
2009
Phase I Amount
$179,333
Sexual dysfunction is one of the most prevalent and persistent problems after cancer treatment. This Fast Track STTR will create and evaluate a multimedia educational and counseling tool to promote recovery of sexual satisfaction in men treated for cancer. Second Manhood: Recovering Your Sex Life after Cancer will be viewable over the internet, on a CD or DVD, or in printed form. It will help men understand how cancer treatments cause sexual problems, learn self-help strategies to improve sexual function, and optimize use of medical treatments. Partners will get advice, self-help exercises, and communication skills training to enhance their role in resolving sexual problems. For health care professionals, we are creating the Follow-Through System for Male Sexual Dysfunction (FT) to improve the quality and continuity of care. It will provide scheduled assessments, using Interactive Voice Recording (IVR) telephony. Scheduled symptom reports with rapid responses from the clinic staff should enhance the success of treatments for erectile dysfunction, preventing the common problem of men discontinuing a prescribed treatment, and then giving up. Phase I: Aim 1 is to use focus groups and interviews to tailor the text and video vignette components of Second Manhood (SM) to a diverse audience. We will assess 130 cancer survivors of varying ethnicity, sexual orientation, age, relationship status, and cancer history. Aim 2 is to use interviews with expert health care professionals (HCP's) to design and create the FT communication interface, pilot testing it in our Sexual Medicine Clinic at UT M. D. Anderson Cancer Center. A communication skills manual for HCP's will also be created. Phase II: We will recruit 360 men from this clinic and from a county hospital. All will be cancer survivors with no current evidence of disease, off active treatment, and seeking help for sexual dysfunction. Partners will be encouraged to participate. We will use adaptive randomization to assign men to one of three groups: Usual Care in the Sexual Medicine clinic (UC), UC + SM, or UC + SM + FT. Those receiving SM will be instructed to view and interact with the application and carry out behavioral homework. All men will complete a brief questionnaire on symptoms via the IVR at baseline, 12 weeks, and 24 weeks. The IVR will call FT group men and partners at 2, 4, 6, and 8 weeks to complete the Treatment Satisfaction Scale (TSS). FT group members will also be encouraged to initiate calls with questions or problems. A mid-level practitioner hired for the study will follow both SM groups. Men will complete additional brief questionnaires at baseline, 12 and 24 weeks assessing overall distress, marital satisfaction, quality of life, and a broad spectrum of sexual function. The hypothesis is that improvements in sexual function and satisfaction will be significantly greater at follow-up for the SM and SM + FT groups than the UC group, but the FT group will also have significantly better outcomes than the SM group. Partner participation and extent of website usage may be moderating variables. All participants will complete a program evaluation form at week 24. During Phase II an IVR-based Sexual Medicine Hotline will be piloted to facilitate both self- and HCP referrals to the Sexual Medicine Clinic.

Public Health Relevance:
According to the office of Cancer Survivorship, about 3,050,000 men in the United States are survivors of prostate, colorectal, or bladder cancer, which means at least 1,525,000 suffer from cancer-related sexual dysfunction. Research indicates that less than 20 percent of men end up satisfied with their recovery from sexual problems, even though 60 percent are distressed about them, and most try some type of medical help. Second Manhood provides education and counseling using multimedia technology to help men and their partners resolve cancer-related sexual dysfunction. A companion product, the Follow-Through System for Male Sexual Dysfunction uses Interactive Voice Recording (IVR) telephony to improve the consistency and quality of medical care for sexual problems.

Public Health Relevance Statement:
Project Narrative According to the office of Cancer Survivorship, about 3,050,000 men in the United States are survivors of prostate, colorectal, or bladder cancer, which means at least 1,525,000 suffer from cancer-related sexual dysfunction. Research indicates that less than 20% of men end up satisfied with their recovery from sexual problems, even though 60% are distressed about them, and most try some type of medical help. Second Manhood provides education and counseling using multimedia technology to help men and their partners resolve cancer-related sexual dysfunction. A companion product, the Follow-Through System for Male Sexual Dysfunction uses Interactive Voice Recording (IVR) telephony to improve the consistency and quality of medical care for sexual problems.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Cancer; Clinical Research; Clinical Trials; Health Services; Mind and Body; Prostate Cancer; Rehabilitation; Urologic Diseases

Project Terms:
Active Follow-up; Address; Adherence; Adherence (attribute); Advocacy; African American; Afro American; Afroamerican; After Care; After-Treatment; Aftercare; Age; Age Group Unspecified; Aged 65 and Over; Ally; American Cancer Society; Animation; Animation (PT); Animation [Publication Type]; Appointment; Asians; Attitude; Behavioral; Belief; Black Populations; Black or African American; Booklets; Books; Brochures; Cancer Center; Cancer Patient; Cancer Survivor; Cancer Survivorship; Cancer Treatment; Cancer of Bladder; Cancer of Prostate; Cancer of Urinary Bladder; Cancer, Oncology; Cancers; Cannot achieve a pregnancy; Carcinoma of the Rectum; Caring; Classification; Clinic; Clinical; Code; Coding System; Collaborations; Colon or Rectum; Colorectal; Comment; Comment (PT); Comment [Publication Type]; Commentary; Commentary (PT); Commit; Communication; Companions; Computer Programs; Computer software; Consult; Continuity of Care; Continuity of Patient Care; Continuum of Care; Controlled Clinical Trials, Randomized; Counseling; Counselor; County Hospitals; Couples; Data; Development; Difficulty conceiving; Disease; Disorder; Distress; Doctor's Assistants; Dysfunction; Editorial Comment; Editorial Comment (PT); Education; Educational aspects; Elderly; Elderly, over 65; Erectile dysfunction; Ethnic Origin; Ethnicity; Ethnicity aspects; Evaluation; Exercise; Exercise, Physical; Exposure to; Fecundability; Fecundity; Feedback; Fertility; Focus Groups; Functional disorder; Funding; Genital System, Male, Prostate; Goals; Grant; Group Interviews; Health Care Professional; Health Care Providers; Health Personnel; Health Professional; Health Services; Health profession; Healthcare Providers; Healthcare professional; Healthcare worker; Heterosexuals; Hispanic Populations; Hispanics; Hispanics or Latinos; History; Hotlines; Human Prostate; Human Prostate Gland; Iatrogenic Cancer; Individual; Infertility; Insurance Coverage; Insurance Status; Internet; Intervention; Intervention Strategies; Interview; Journals; Latino Population; Learning; Licensing; Life; MDACC; Magazine; Male sexual dysfunction; Malignant Bladder Neoplasm; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; Malignant Neoplasms; Malignant Tumor; Malignant Tumor of the Bladder; Malignant Tumor of the Prostate; Malignant neoplasm of prostate; Malignant neoplasm of urinary bladder; Malignant prostatic tumor; Manuals; Manuscripts; Marketing; Medical; Medicine; Mental Health; Mental Hygiene; Methodology, Research; Metric; Multimedia; Multimedium; NCI; NCI Organization; National Cancer Institute; Needs Assessment; Nurses; Orientation, Sexual; Out-patients; Outcome; Outcome Measure; Outpatients; PROV; Pamphlets; Participant; Patient Education; Patient Instruction; Patient Training; Patients; Pattern; Pelvic; Pelvic Region; Pelvis; Personnel, Nursing; Pharmaceutical Agent; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Phase; Phone; Physical Health Services / Rehabilitation; Physician Assistants; Physician Self-Referral; Physicians; Physicians' Extenders; Physiopathology; Prevalence; Printing; Private Practice; Production; Professional counselor; Program Evaluation; Programs (PT); Programs [Publication Type]; Prostate; Prostate CA; Prostate Cancer; Prostate Gland; Prostatic Cancer; Prostatic Gland; Provider; Psychological Health; Published Comment; QOC; QOL; Qualitative Research; Quality of Care; Quality of life; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Reading; Recording of previous events; Recovery; Recruitment Activity; Rectal Cancer; Rectal Carcinoma; Rectum Cancer; Rehabilitation; Rehabilitation therapy; Rehabilitation, Medical; Reporting; Research; Research Methodology; Research Methods; Research Support; Rights; Role; SBIR; SBIRS (R43/44); SCHED; STTR; SUBCAT; SUBGP; Schedule; Science of Medicine; Services; Sex Disorders; Sex Functioning; Sex Orientation; Sexual Dysfunction; Sexuality; Site; Small Business Innovation Research; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Social Workers; Software; Spanish Origin; Sperm Banks; Structure; Subcategory; Subgroup; Survivors; Symptoms; System; System, LOINC Axis 4; Systematics; TXT; Technology; Telephone; Telephone Hotlines; Testing; Text; Therapy Related Malignant Neoplasm; Therapy Related Malignant Tumor; Therapy-Associated Cancers; Therapy-Related Cancer; Time; TimeLine; Training; Treatment Efficacy; Treatment-Associated Cancer; Treatment-Related Cancer; United States; University of Texas M D Anderson Cancer Center; University of Texas MD Anderson Cancer Center; Urinary Bladder Malignant Tumor; Urology; Videotape; Viewpoint; Viewpoint (PT); Voice; WWW; Woman; Work; Writing; active method; advanced age; age group; animation; anticancer therapy; base; behavior change; black American; cancer location; cancer site; cancer therapy; cancer type; commercial application; computer program/software; coping; design; designing; disease/disorder; elders; evidence base; experience; fatherhood; follow-up; geriatric; health care personnel; health care service; health care worker; health provider; healthcare personnel; help seeking; help-seeking behavior; hispanic community; improved; infertile; information gathering; interventional strategy; late life; later life; male; male group; malignancy; man; man's; medical personnel; meetings; member; men; men's; men's group; neoplasm/cancer; older adult; older person; oncology; oriental; pathophysiology; peer; prevent; preventing; primary outcome; programs; prototype; public health relevance; randomisation; randomization; randomized trial; randomly assigned; rapid detection; recruit; rehabilitative; response; satisfaction; self help; senior citizen; sex; sexual functioning; skills; skills training; social role; speech recognition; success; technological innovation; therapeutic efficacy; therapeutically effective; tool; treatment as usual; treatment provider; unable to bear children; usability; web; web site; world wide web

Phase II

Contract Number: 4R42CA139822-02
Start Date: 9/28/09    Completed: 8/31/13
Phase II year
2010
(last award dollars: 2014)
Phase II Amount
$2,079,351

Sexual dysfunction is one of the most prevalent and persistent problems after cancer treatment. This Fast Track STTR will create and evaluate a multimedia educational and counseling tool to promote recovery of sexual satisfaction in men treated for cancer. Second Manhood: Recovering Your Sex Life after Cancer will be viewable over the internet, on a CD or DVD, or in printed form. It will help men understand how cancer treatments cause sexual problems, learn self-help strategies to improve sexual function, and optimize use of medical treatments. Partners will get advice, self-help exercises, and communication skills training to enhance their role in resolving sexual problems. For health care professionals, we are creating the Follow-Through System for Male Sexual Dysfunction (FT) to improve the quality and continuity of care. It will provide scheduled assessments, using Interactive Voice Recording (IVR) telephony. Scheduled symptom reports with rapid responses from the clinic staff should enhance the success of treatments for erectile dysfunction, preventing the common problem of men discontinuing a prescribed treatment, and then giving up. Phase I: Aim 1 is to use focus groups and interviews to tailor the text and video vignette components of Second Manhood (SM) to a diverse audience. We will assess 130 cancer survivors of varying ethnicity, sexual orientation, age, relationship status, and cancer history. Aim 2 is to use interviews with expert health care professionals (HCP's) to design and create the FT communication interface, pilot testing it in our Sexual Medicine Clinic at UT M. D. Anderson Cancer Center. A communication skills manual for HCP's will also be created. Phase II: We will recruit 360 men from this clinic and from a county hospital. All will be cancer survivors with no current evidence of disease, off active treatment, and seeking help for sexual dysfunction. Partners will be encouraged to participate. We will use adaptive randomization to assign men to one of three groups: Usual Care in the Sexual Medicine clinic (UC), UC + SM, or UC + SM + FT. Those receiving SM will be instructed to view and interact with the application and carry out behavioral homework. All men will complete a brief questionnaire on symptoms via the IVR at baseline, 12 weeks, and 24 weeks. The IVR will call FT group men and partners at 2, 4, 6, and 8 weeks to complete the Treatment Satisfaction Scale (TSS). FT group members will also be encouraged to initiate calls with questions or problems. A mid-level practitioner hired for the study will follow both SM groups. Men will complete additional brief questionnaires at baseline, 12 and 24 weeks assessing overall distress, marital satisfaction, quality of life, and a broad spectrum of sexual function. The hypothesis is that improvements in sexual function and satisfaction will be significantly greater at follow-up for the SM and SM + FT groups than the UC group, but the FT group will also have significantly better outcomes than the SM group. Partner participation and extent of website usage may be moderating variables. All participants will complete a program evaluation form at week 24. During Phase II an IVR-based Sexual Medicine Hotline will be piloted to facilitate both self- and HCP referrals to the Sexual Medicine Clinic. , ,

Public Health Relevance:
According to the office of Cancer Survivorship, about 3,050,000 men in the United States are survivors of prostate, colorectal, or bladder cancer, which means at least 1,525,000 suffer from cancer-related sexual dysfunction. Research indicates that less than 20 percent of men end up satisfied with their recovery from sexual problems, even though 60 percent are distressed about them, and most try some type of medical help. Second Manhood provides education and counseling using multimedia technology to help men and their partners resolve cancer-related sexual dysfunction. A companion product, the Follow-Through System for Male Sexual Dysfunction uses Interactive Voice Recording (IVR) telephony to improve the consistency and quality of medical care for sexual problems.

Thesaurus Terms:
Active Follow-Up;Address;Adherence;Adherence (Attribute);Advocacy;African American;Afro American;Afroamerican;After Care;After-Treatment;Aftercare;Age;Age Group Unspecified;Aged 65 And Over;Ally;American Cancer Society;Animation;Animation (Pt);Animation [publication Type];Appointment;Asians;Attitude;Behavioral;Belief;Black Populations;Black Or African American;Booklets;Books;Brochures;Cancer Center;Cancer Patient;Cancer Survivor;Cancer Survivorship;Cancer Treatment;Cancer Of Bladder;Cancer Of Prostate;Cancer Of Urinary Bladder;Cancer, Oncology;Cancers;Cannot Achieve A Pregnancy;Carcinoma Of The Rectum;Caring;Clinic;Clinical;Code;Coding System;Collaborations;Colon Or Rectum;Colorectal;Comment;Comment (Pt);Comment [publication Type];Commentary;Commentary (Pt);Commit;Communication;Companions;Computer Programs;Computer Software;Consult;Continuity Of Care;Continuity Of Patient Care;Continuum Of Care;Counseling;Counselor;County Hospitals;Couples;Data;Development;Difficulty Conceiving;Disease;Disorder;Distress;Doctor's Assistants;Dysfunction;Editorial Comment;Editorial Comment (Pt);Education;Educational Aspects;Elderly;Elderly, Over 65;Erectile Dysfunction;Ethnic Origin;Ethnicity;Ethnicity Aspects;Evaluation;Exercise;Exercise, Physical;Exposure To;Fecundability;Fecundity;Feedback;Fertility;Focus Groups;Functional Disorder;Funding;Genital System, Male, Prostate;Goals;Grant;Group Interviews;Health Care Professional;Health Care Providers;Health Personnel;Health Professional;Health Services;Health Profession;Healthcare Providers;Healthcare Professional;Healthcare Worker;Heterosexuals;Hispanic Populations;Hispanics;Hispanics Or Latinos;History;Hotlines;Human Prostate;Human Prostate Gland;Iatrogenic Cancer;Individual;Infertility;Insurance Coverage;Insurance Status;Internet;Intervention;Intervention Strategies;Interview;Journals;Latino Population;Learning;Licensing;Life;Mdacc;Magazine;Male Sexual Dysfunction;Malignant Bladder Neoplasm;Malignant Neoplasm Therapy;Malignant Neoplasm Treatment;Malignant Neoplasms;Malignant Tumor;Malignant Tumor Of The Bladder;Malignant Tumor Of The Prostate;Malignant Neoplasm Of Prostate;Malignant Neoplasm Of Urinary Bladder;Malignant Prostatic Tumor;Manuals;Manuscripts;Marketing;Medical;Medicine;Mental Health;Mental Hygiene;Methodology, Research;Metric;Multimedia;Multimedium;Nci;Nci Organization;National Cancer Institute;Needs Assessment;Nurses;Orientation, Sexual;Out-Patients;Outcome;Outcome Measure;Outpatients;Prov;Pamphlets;Participant;Patient Education;Patient Instruction;Patient Training;Patients;Pattern;Pelvic;Pelvic Region;Pelvis;Personnel, Nursing;Pharmaceutical Agent;Pharmaceuticals;Pharmacologic Substance;Pharmacological Substance;Phase;Phone;Physical Health Services / Rehabilitation;Physician Assistants;Physician Self-Referral;Physicians;Physicians' Extenders;Physiopathology;Prevalence;Printing;Private Practice;Production;Professional Counselor;Program Evaluation;Programs (Pt);Programs [publication Type];Prostate;Prostate Ca;Prostate Cancer;Prostate Gland;Prostatic Cancer;Prostatic Gland;Provider;Psychological Health;Published Comment;Qoc;Qol;Qualitative Research;Quality Of Care;Quality Of Life;Questionnaires;Randomized;Reading;Recording Of Previous Events;Recovery;Recruitment Activity;Rectal Cancer;Rectal Carcinoma;Rectum Cancer;Rehabilitation;Rehabilitation Therapy;Rehabilitation, Medical;Reporting;Research;Research Methodology;Research Methods;Research Support;Rights;Role;Sbir;Sbirs (R43/44);Sched;Sttr;Subcat;Subgp;Schedule;Science Of Medicine;Services;Sex Disorders;Sex Functioning;Sex Orientation;Sexual Dysfunction;Sexuality;Site;Small Business Innovation Research;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Social Workers;Software;Spanish Origin;Sperm Banks;Structure;Subcategory;Subgroup;Survivors;Symptoms;System;System, Loinc Axis 4;Txt;Technology;Telephone;Telephone Hotlines;Testing;Text;Therapy Related Malignant Neoplasm;Therapy Related Malignant Tumor;Therapy-Associated Cancers;Therapy-Related Cancer;Time;Timeline;Training;Treatment Efficacy;Treatment-Associated Cancer;Treatment-Related Cancer;United States;University Of Texas M D Anderson Cancer Center;University Of Texas Md Anderson Cancer Center;Urinary Bladder Malignant Tumor;Urology;Videotape;Viewpoint;Viewpoint (Pt);Voice;Www;Woman;Work;Writing;Active Method;Advanced Age;Age Group;Animation;Anticancer Therapy;Base;Behavior Change;Black American;Cancer Location;Cancer Site;Cancer Therapy;Cancer Type;Commercial Application;Computer Program/Software;Coping;Design;Designing;Disease/Disorder;Elders;Evidence Base;Experience;Fatherhood;Follow-Up;Geriatric;Health Care Personnel;Health Care Service;Health Care Worker;Health Provider;Healthcare Personnel;Help Seeking;Help-Seeking Behavior;Hispanic Community;Improved;Infertile;Information Gathering;Interventional Strategy;Late Life;Later Life;Male;Male Group;Malignancy;Man;Man's;Medical Personnel;Meetings;Member;Men;Men's;Men's Group;Neoplasm/Cancer;Older Adult;Older Person;Oncology;Oriental;Pathophysiology;Peer;Prevent;Preventing;Primary Outcome;Programs;Prototype;Public Health Relevance;Randomisation;Randomization;Randomized Trial;Randomly Assigned;Rapid Detection;Recruit;Rehabilitative;Response;Satisfaction;Self Help;Senior Citizen;Sex;Sexual Functioning;Skills;Skills Training;Social Role;Speech Recognition;Success;Technological Innovation;Therapeutic Efficacy;Therapeutically Effective;Tool;Treatment As Usual;Treatment Provider;Unable To Bear Children;Usability;Web;Web Site;World Wide Web