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Intimacy Enhancement for Breast Cancer (C-QOL Trial)

N/A
Recruiting
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is female
Patient lives with a romantic partner (same or opposite sex) for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 9 weeks, 6 months
Awards & highlights

C-QOL Trial Summary

This trial will study how to improve quality of life for women with metastatic breast cancer and their partners.

Who is the study for?
This trial is for women with stage IV breast cancer who live with a romantic partner. They must be at least 18 years old, have been in the relationship for over six months, and experience sexual concerns. Partners also need to be adults and both must speak English. Those with severe mental issues, other cancers (except non-melanoma skin cancer), current couple therapy, pregnancy, hearing impairments or without phone access can't join.Check my eligibility
What is being tested?
The study aims to improve sexual quality of life for women with metastatic breast cancer and their partners through two approaches: 'Adapted Intimacy Enhancement' which involves tailored counseling sessions, and 'Intimacy Facts and Resources' providing educational materials.See study design
What are the potential side effects?
Since this trial focuses on psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional distress or discomfort discussing intimate topics during the intervention.

C-QOL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I have been living with my romantic partner for at least 6 months.
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I am 18 years old or older.
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My partner or spouse is 18 years old or older.
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My breast cancer has spread to other parts of my body.

C-QOL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 9 weeks, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 weeks, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns
Change in Self-Reported Patient Sexual Distress
Change in Self-Reported Patient Sexual Function
Secondary outcome measures
Change in Partner Self-Reported Anxiety
Change in Partner Self-Reported Depressive Symptoms
Change in Partner Self-Reported Intimacy-Related Communication
+8 more

C-QOL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adapted Intimacy EnhancementExperimental Treatment2 Interventions
Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer
Group II: Intimacy Facts & ResourcesActive Control1 Intervention
Participants read a booklet about intimacy and metastatic breast cancer.

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,397 Total Patients Enrolled
15 Trials studying Breast Cancer
4,082 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,345 Total Patients Enrolled
33 Trials studying Breast Cancer
8,884 Patients Enrolled for Breast Cancer

Media Library

Adapted Intimacy Enhancement Clinical Trial Eligibility Overview. Trial Name: NCT05636943 — N/A
Breast Cancer Research Study Groups: Intimacy Facts & Resources, Adapted Intimacy Enhancement
Breast Cancer Clinical Trial 2023: Adapted Intimacy Enhancement Highlights & Side Effects. Trial Name: NCT05636943 — N/A
Adapted Intimacy Enhancement 2023 Treatment Timeline for Medical Study. Trial Name: NCT05636943 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of this medical experiment?

"This clinical trial has two primary objectives. The first is to measure the Change in Self-Reported Patient Sexual Distress over a Baseline, 9 week and 6 month period. Additionally, secondary outcomes will be tracked including Partner Self-Efficacy for Coping with Sexual Concerns, Patient Relationship Intimacy, and partner (male) Self-Reported Sexual Function which are measured using the Miller Social Intimacy Scale (MSIS), International Index of Erectile Function (IIEF), respectively."

Answered by AI

Is there an opportunity for individuals to enroll in this research program?

"Affirmative, the information on clinicaltrials.gov demonstrates that this medical research is presently in need of participants. The trial was inaugurated on January 1st 2021 and revised most recently on December 5th 2022. There are 112 patients who must be recruited from a single site for this study to proceed."

Answered by AI

How many participants are being observed in this research project?

"Affirmative. As evidenced by the clinicaltrials.gov database, this research endeavour is currently enrolling patients which was initiated on January 1st 2021 and last revised on December 5th 2022. 112 individuals are needed from one facility for full participation."

Answered by AI
~0 spots leftby Mar 2024