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Active, Not Recruiting

NCT Number: 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 partners.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is female
  • Patient is at least 18 years old
  • Patient has a diagnosis of metastatic (stage IV) breast cancer
  • Patient has a partner or spouse who is at least 18 years old
  • Patient lives with a romantic partner (same or opposite sex) for at least 6 months
  • Patient scores 3 or above on Patient Care Monitor sexual concerns item (range: 0-10)

Exclusion criteria

  • Patient or partner is not able to speak and read English
  • Patient or partner has a hearing impairment
  • Patient or partner medically unable to participate as judged by physician/in medical record or by self-report
  • Patient and partner do not have reliable telephone access
  • Patient has overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, physician or referring source, or self-report
  • Patient past or current history of any cancer other than non-melanoma skin cancer or breast cancer
  • Patient is currently participating in couple/marital therapy
  • Patient is currently pregnant

Treatment and study plan

Adapted Intimacy Enhancement

Behavioral

Participants attend four virtual sessions (60-75 minutes) with a couples' coach consisting of education and skills training to enhance physical and emotional intimacy.

Intimacy Facts and Resources

Behavioral

Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

Primary outcomes

  1. Change in Self-Reported Patient Sexual Function

    Time frame: Baseline, 9 weeks, 6 months

    Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.

  2. Change in Self-Reported Patient Sexual Distress

    Time frame: Baseline, 9 weeks, 6 months

    Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress.

  3. Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns

    Time frame: Baseline, 9 weeks, 6 months

    Patient self-efficacy for coping with sexual concerns will be measured using 3 items asking how certain the patient is that she can deal with issues related to physical intimacy. Scores range from 0 to 10, with higher scores indicating higher self-efficacy. Change in patient mean self-efficacy score over time will be reported, with a positive change score reflecting an increase in self-efficacy.

Secondary outcomes

  1. Change in Patient Self-Reported Intimacy-Related Communication

    Time frame: Baseline, 9 weeks, 6 months

    Sexual communication is assessed through a brief 6-item version of the Dyadic Sexual Communication Scale (DSCS). Total scale scores range from 1 to 36. Higher scores indicate higher quality of intimacy-related communication. Change in patient mean score over time will be reported. Positive mean change scores indicate increase in quality of sexual communication.

  2. Change in Patient Self-Reported Relationship Intimacy

    Time frame: Baseline, 9 weeks, 6 months

    Patient self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.

  3. Change in Patient Self-Reported Anxiety

    Time frame: Baseline, 9 weeks, 6 months

    Patients' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.

  4. Change in Patient Self-Reported Depressive Symptoms

    Time frame: Baseline, 9 weeks, 6 months

    Patients' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.

  5. Change in Self-Reported Partner Sexual Function

    Time frame: Baseline, 9 weeks, 6 months

    Partners' (male) self-reported sexual function will be measured using the 15-item International Index of Erectile Function (IIEF). Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.

  6. Change in Self-Reported Partner Sexual Distress

    Time frame: Baseline, 9 weeks, 6 months

    Partner sexual distress will be measured using the 25-item Index of Sexual Satisfaction (ISS). Total scale scores range from 0 to 100. Higher scores indicate higher levels of sexual distress. Change in partner mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress.

  7. Change in Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns

    Time frame: Baseline, 9 weeks, 6 months

    Partner self-efficacy for coping with sexual concerns will be measured using 3 items asking how certain the partner is that he/she can deal with issues related to physical intimacy. Scores range from 0 to 10, with higher scores indicating higher self-efficacy. Change in partner mean self-efficacy score over time will be reported, with a positive change score reflecting an increase in self-efficacy.

  8. Change in Partner Self-Reported Intimacy-Related Communication

    Time frame: Baseline to 9 weeks

    Sexual communication is assessed through a brief 6-item version of the Dyadic Sexual Communication Scale (DSCS). Total scale scores range from 1 to 36. Higher scores indicate higher quality of intimacy-related communication. Change in partner mean score over time will be reported. Positive mean change scores indicate increase in quality of sexual communication.

  9. Change in Partner Self-Reported Relationship Intimacy

    Time frame: Baseline, 9 weeks, 6 months

    Partner self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in partner mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.

  10. Change in Partner Self-Reported Anxiety

    Time frame: Baseline, 9 weeks, 6 months

    Partners' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.

  11. Change in Partner Self-Reported Depressive Symptoms

    Time frame: Baseline, 9 weeks, 6 months

    Partners' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Quality of Life for Couples Facing Metastatic Breast Cancer

Acronym: C-QOL

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2022
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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