Metastatic Breast CancerC-QOLNCT05636943
Couples' QOL in Metastatic Breast Cancer
A study testing Adapted Intimacy Enhancement and Intimacy Facts and Resources in people with Metastatic Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Adapted Intimacy Enhancement and Intimacy Facts and Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Quality of Life for Couples Facing 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Adapted Intimacy Enhancement, Intimacy Facts and Resources
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Intimacy EnhancementBehavioural
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 ResourcesBehavioural
Self-guided booklet of readings/resources about intimacy and metastatic breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Adapted Intimacy Enhancement | Experimental | Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer Receives: Behavioral: Adapted Intimacy Enhancement; Behavioral: Intimacy Facts and Resources |
| Intimacy Facts & Resources | Active comparator | Participants read a booklet about intimacy and metastatic breast cancer. Receives: Behavioral: Intimacy Facts and Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Reported Patient Sexual Function
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.
Measured: Baseline, 9 weeks, 6 months
Change in Self-Reported Patient Sexual Distress
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.
Measured: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns
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.
Measured: Baseline, 9 weeks, 6 months
Secondary outcomes (11)
Change in Patient Self-Reported Intimacy-Related Communication
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.
Measured: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Relationship Intimacy
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.
Measured: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Anxiety
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.
Measured: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Depressive Symptoms
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.
Measured: Baseline, 9 weeks, 6 months
Change in Self-Reported Partner Sexual Function
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.
Measured: Baseline, 9 weeks, 6 months
Change in Self-Reported Partner Sexual Distress
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.
Measured: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns
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.
Measured: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Intimacy-Related Communication
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.
Measured: Baseline to 9 weeks
Change in Partner Self-Reported Relationship Intimacy
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.
Measured: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Anxiety
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.
Measured: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Depressive Symptoms
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.
Measured: Baseline, 9 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jan 2021
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636943
- Sponsor's protocol ID
- 20-1039
- Acronym
- C-QOL
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2022
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life for Couples Facing Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05636943
- Acronym / sponsor ID
- C-QOL / 20-1039
- Conditions
- Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Intimacy Enhancement | Experimental | Behavioral: Adapted Intimacy Enhancement, Behavioral: Intimacy Facts and ResourcesParticipants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer |
| Intimacy Facts & Resources | Active comparator | Behavioral: Intimacy Facts and ResourcesParticipants read a booklet about intimacy and metastatic breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Intimacy EnhancementParticipants attend four virtual sessions (60-75 minutes) with a couples' coach consisting of education and skills training to enhance physical and emotional intimacy. | Behavioural | Adapted Intimacy Enhancement |
| Intimacy Facts and ResourcesSelf-guided booklet of readings/resources about intimacy and metastatic breast cancer | Behavioural | Adapted Intimacy Enhancement, Intimacy Facts & Resources |
Primary outcome
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.
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.
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.
11 secondary outcomes
Change in Patient Self-Reported Intimacy-Related Communication
Time frame: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Relationship Intimacy
Time frame: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Anxiety
Time frame: Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Depressive Symptoms
Time frame: Baseline, 9 weeks, 6 months
Change in Self-Reported Partner Sexual Function
Time frame: Baseline, 9 weeks, 6 months
Change in Self-Reported Partner Sexual Distress
Time frame: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns
Time frame: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Intimacy-Related Communication
Time frame: Baseline to 9 weeks
Change in Partner Self-Reported Relationship Intimacy
Time frame: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Anxiety
Time frame: Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Depressive Symptoms
Time frame: Baseline, 9 weeks, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Intimacy Enhancement and Intimacy Facts and Resources in people with Metastatic Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Reported Patient Sexual Function (time frame: Baseline, 9 weeks, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.