Intimacy Enhancement for Breast Cancer

(C-QOL Trial)

Overseen By Jennifer B. Reese, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Hearing impairment, Cognitive dysfunction, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women with metastatic breast cancer and their partners improve their sexual quality of life. Participants will either attend Adapted Intimacy Enhancement sessions or receive a booklet with information about intimacy and metastatic breast cancer. Women with stage IV breast cancer who live with a romantic partner and have concerns about intimacy might find this trial fitting.

As an unphased study, this trial offers a unique opportunity to explore new ways to enhance intimacy and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for women with metastatic breast cancer?

Research shows that the Adapted Intimacy Enhancement treatment is safe. Studies have tested similar sessions with couples facing colorectal cancer and found no serious side effects. These sessions help couples communicate more openly about intimacy and are generally well-received.

For women with metastatic breast cancer, the same method includes sessions that encourage open discussions about intimacy. No reports of harmful effects have emerged from these discussions, making it a low-risk option for those interested.

The other treatment option, Intimacy Facts and Resources, involves reading a booklet about intimacy and breast cancer. This educational approach carries no known safety risks.

Overall, both treatments are non-invasive and aim to improve quality of life without using drugs or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Intimacy Enhancement for Breast Cancer trial because it explores new ways to support emotional and relational health for women with metastatic breast cancer. Unlike traditional treatments that primarily focus on medical and physical aspects, this trial investigates how tailored intimacy enhancement sessions, combined with educational resources, can improve intimacy and overall quality of life. By addressing these often-overlooked aspects, the trial seeks to enrich the holistic care approach for breast cancer patients, potentially offering a more comprehensive treatment experience.

What evidence suggests that this trial's treatments could be effective for improving sexual quality of life in women with metastatic breast cancer?

Research has shown that the Adapted Intimacy Enhancement treatment, which participants in this trial may receive, can improve the sexual quality of life for women with advanced breast cancer. In earlier studies, couples who participated in a similar program reported better sexual function and satisfaction. Women with breast cancer in these programs also experienced less distress about their sex lives and felt more positive about their bodies. This treatment includes sessions focused on building intimacy and sharing tips on coping with cancer. Meanwhile, another group in this trial will receive Intimacy Facts and Resources, which involves reading a booklet about intimacy and metastatic breast cancer. Overall, evidence suggests these approaches effectively enhance intimacy and quality of life for couples dealing with cancer. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

If you rate your concerns about sexual matters as 3 or higher on a scale from 0 to 10, you may not be able to participate.

I am female.

I have been living with my romantic partner for at least 6 months.

Exclusion Criteria

Patient or partner medically unable to participate as judged by physician/in medical record or by self-report

You have significant problems with memory or thinking, or serious mental health issues such as feeling extremely sad or thinking about hurting yourself.

Patient or partner is not able to speak and read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer

9 weeks

Follow-up

Participants are monitored for changes in self-reported sexual function, distress, and intimacy-related communication

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Intimacy Enhancement
• Intimacy Facts and Resources

Trial Overview 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.

How Is the Trial Designed?

Group I: Adapted Intimacy Enhancement Experimental Treatment 2 Interventions

Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer

Group II: Intimacy Facts & Resources Active Control 1 Intervention

Participants read a booklet about intimacy and metastatic breast cancer.

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

A 6-week psycho-educational group intervention for breast cancer survivors showed modest improvements in relationship adjustment and sexual satisfaction, particularly benefiting those who were least satisfied with their sexual relationships.

While the intervention did not significantly change emotional functioning compared to the control group, it highlights a potential approach for addressing ongoing intimacy issues in breast cancer survivors, which can be implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing intimacy and partner communication after breast cancer: a randomized controlled group intervention. Rowland, JH., Meyerowitz, BE., Crespi, CM., et al.[2021]

The couple-based Intimacy Enhancement (IE) intervention, delivered via telephone to 29 breast cancer survivors and their partners, was found to be feasible and acceptable, indicating it could be a valuable resource for addressing sexual concerns post-treatment.

The IE intervention showed medium to large positive effects on sexual and psychosocial outcomes for survivors, suggesting it effectively enhances intimacy and well-being, although the impact on relationship outcomes was less pronounced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of a couple-based intervention addressing sexual concerns for breast cancer survivors. Reese, JB., Smith, KC., Handorf, E., et al.[2020]

A study of 31 breast cancer survivors who declined participation in a couple-based Intimacy Enhancement intervention revealed that the main reasons for refusal were time commitment (74%) and lack of partner interest (32%).

Most participants expressed a desire for their partners to be involved in addressing sexual concerns, with a preference for resources like informational websites (45%) and professional meetings (26%), suggesting that more flexible and brief intervention formats could improve participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why do breast cancer survivors decline a couple-based intimacy enhancement intervention trial? Reese, JB., Sorice, KA., Oppenheimer, NM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5034713/

Adapting a Couple-based Intimacy Enhancement Intervention ... The objective of this study was to adapt a telephone-based Intimacy Enhancement intervention, previously tested in couples facing colorectal cancer, to the ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-13977

Adapted Intimacy Enhancement Intervention for the ... This clinical trial studies the use of a couple-based sexual quality of life intervention called Adapted Intimacy Enhancement (AIE) in improving sexual and ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.35685

Efficacy of a couple‐based intervention addressing sexual ... Model-based estimates of intervention effects showed greater improvements in survivors' overall sexual function, sexual satisfaction, arousal, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925000766

Effects of a sexual health enhancement program for ... The program addressed sexual health challenges in women with breast cancer. Sexual distress, body image, and knowledge were improved in breast cancer survivors.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05636943

NCT05636943 | Couples' QOL in Metastatic Breast Cancer The primary objectives of this study are to adapt and evaluate a sexual quality of life intervention in women with metastatic breast cancer and their ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27657981/

Adapting a couple-based intimacy enhancement intervention ... The objective of this study was to adapt a telephone-based intimacy enhancement intervention, previously tested in couples facing colorectal cancer, to the ...