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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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 partners.

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 data supports the effectiveness of the treatment Adapted Intimacy Enhancement for breast cancer?

Research shows that the Intimacy Enhancement treatment, adapted for breast cancer survivors, had medium to large positive effects on sexual and psychosocial outcomes, helping improve sexual concerns and intimate relationships. This suggests it could be beneficial for breast cancer survivors facing similar issues. ^{1 2 3 4 5}

Is the Intimacy Enhancement intervention safe for humans?

The Intimacy Enhancement intervention has been tested in studies with breast and colorectal cancer patients, showing it is feasible and acceptable, which suggests it is generally safe for humans. ^{1 2 4 6 7}

How is the Intimacy Enhancement treatment for breast cancer unique?

The Intimacy Enhancement treatment is unique because it is a couple-based therapy delivered over the phone, specifically designed to address sexual concerns and improve intimacy for breast cancer survivors and their partners. It combines techniques from cognitive behavioral couple therapy and sex therapy, making it different from standard medical treatments that typically focus on physical symptoms. ^{1 2 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adapting a couple-based intimacy enhancement intervention to breast cancer: A developmental study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of a couple-based intervention addressing sexual concerns for breast cancer survivors. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing intimacy and partner communication after breast cancer: a randomized controlled group intervention. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Why do breast cancer survivors decline a couple-based intimacy enhancement intervention trial? [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

[Effect of PLISSIT model sexual health enhancement program for women with gynecologic cancer and their husbands]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Satisfaction with sex life in sexually active heterosexual couples dealing with breast cancer: a nationwide longitudinal study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of a telephone-based couples intervention for physical intimacy and sexual concerns in colorectal cancer. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of a telephone-based couples intervention for physical intimacy and sexual concerns in colorectal cancer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A review of couple-based interventions for enhancing women's sexual adjustment and body image after cancer. [2009]