A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study

NCT02640131 | Completed

• 1 other identifier: 701840
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.

Conditions

Prostate Cancer; Erectile Dysfunction; Sexual Dysfunction

Keywords

prostate cancer; radical prostatectomy; survivorship; quality of life; erectile dysfunction; sexual dysfunction; feasibility study

Outcome Measures

Primary Outcomes (1)

• Miller Social Intimacy Scale (MSIS)

  Miller Social Intimacy Scale (MSIS):MSIS is a 17-item measure of the maximum level of intimacy currently experienced is used in this study. Each question has a scale of 1-10 with a higher score representing higher level of intimacy.

  At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

Secondary Outcomes (6)

• International Index of Erectile Function (IIEF)

  At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

• Female Sexual Function Inventory (FSFI)

  At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

• Hospital Anxiety and Depression Scale (HADS)

  At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

• Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)

  13-14 months post-radical prostatectomy

• Sexual Health Rehabilitation Record

  3-4 months post-radical prostatectomy;7-8 months post-radical prostatectomy;12-13 months post-radical prostatectomy

Study Arms (2)

BSHR Intervention

EXPERIMENTAL

Couples will attend 30-minute clinic consultations with an Urologist and a Sexual Health Counsellor and receive session-specific chapters of the Kindness, Intimacy, Sexuality and Satisfaction manual over the course of the intervention. The BSHR Intervention involves two complementary components; the bio-medical, and the psychosocial. The bio-medical component for both arms intervention includes an urologist consultation at a pre-operative appointment and 5 f/u appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices. The psychosocial component aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive sexual health counseling and manualized support.

Behavioral: Biomedical Component; Behavioral: Psychosocial Component

Attention Control

ACTIVE COMPARATOR

Survivorship Counseling: Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) and receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: "Nutrition, Exercise, and You Manual". The bio-medical component is the same in both arms. The core topics discussed during over 7 counseling sessions include: preparation for immediate post-surgery recovery, Kegel exercises, nutrition and prostate cancer, exercise and prostate cancer, and maintaining healthy lifestyle change.

Behavioral: Biomedical Component; Behavioral: Attention Control

Interventions

Biomedical Component BEHAVIORAL

Bio-medical: The bio-medical component includes an appointment with urologist pre-operatively and 5 follow-up appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices.

Attention Control; BSHR Intervention

Psychosocial Component BEHAVIORAL

Psychosocial: aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive standardized sexual health counselor (SexHC) counseling and manualized support.

BSHR Intervention

Attention Control BEHAVIORAL

Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) at 3-4, 7-8, and 12-13 months post radical prostatectomy (RP). Couples will receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: Nutrition, Exercise, and You (CPC) manual (a patient self-help manual written by the Princess Margaret Prostate Centre team). The core topics discussed during the counselling sessions include: preparation for immediate post-RP recovery, Kegel exercises, nutrition and prostate cancer (PC), exercise and PC, and maintaining healthy lifestyle change.

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for a Radical Prostatectomy at the Princess Margaret Cancer Centre(open, laparoscopic, robotic) for the first-line treatment of prostate cancer regardless of clinical stage of disease
• are hormone and/or chemotherapy-naïve
• have a sexual partner (heterosexual or homosexual) for at least the past 6 months
• are 18 years of age or older
• Partners of men who meet the above criteria and are 18 years of age or older

You may not qualify if:

• the patient or partner lacks English proficiency
• the patient is on nitrate therapy or has other contra-indications to phosphodiesterase type 5 inhibitors (PDE5i's)
• the patient does not have a sexual partner
• the patient or partner has a medical condition that would preclude safe sexual activity
• the patient has had previous treatment for PC
• the patient has previously and regularly used sexual aids/devices during the course of sexual activity

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

The Prostate Centre, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Andrew G Matthew, PhD, C.Psych

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: December 28, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

CA (1)