Breast CancerNCT03930797
Coping Together After Breast Cancer
A study testing Intimacy Enhancement and Living Healthy Together in people with Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intimacy Enhancement and Living Healthy Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 age 18 years or older
- Patient has a medically confirmed diagnosis of non-recurrent breast cancer (Stages T1-T4, N0-N1, M0)
- Patient completed active treatment (e.g., chemotherapy, radiation therapy, surgery, immunotherapy) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Patient is currently in a partnered relationship that could involve sexual activity
- Partner or spouse is 18 years or older
- Patient lives with a romantic partner for at least 6 months
- Patient has a score of at least 3 on Patient Care Monitor Sexual Concerns screening item
Who cannot join
- Patient or partner is not able to speak and read English, as stated in medical record, as observed by study team member or in self-report
- Patient or partner ECOG Performance score > 2 OR medically unable to participate as judged by physician/in medical record or by self-report
- Patient or partner has a hearing impairment
- 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, including prior 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: Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention
The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes.
Read the detailed description
Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE).
The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups.
- Conditions
- Breast Cancer
- Being tested
- Intimacy Enhancement, Living Healthy Together
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intimacy EnhancementBehavioural
The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
Living Healthy TogetherBehavioural
The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intimacy Enhancement | Experimental | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Receives: Behavioral: Intimacy Enhancement |
| Living Healthy Together | Active comparator | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Receives: Behavioral: Living Healthy Together |
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 up to 6 weeks
Secondary outcomes (10)
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. Change in mean male partner IIEF score over time will be reported. Positive mean change scores indicate increase in sexual functioning.
Measured: Baseline up to 6 weeks
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 up to 6 weeks
Change in Patients' 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 up to 6 weeks
Change in Partners' 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 patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Measured: Baseline up to 6 weeks
Change in Patients' Self-Reported Relationship Quality
Patient self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Measured: Baseline up to 6 weeks
Change in Partners' Self-Reported Relationship Quality
Partner self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Measured: Baseline up to 6 weeks
Change in Patients' 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 up to 6 weeks
Change in Partners' 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 up to 6 weeks
Change in Patients' 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 up to 6 weeks
Change in Partners' 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 up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start24 May 2019
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930797
- Sponsor's protocol ID
- 18-1025
- Other IDs
- 1R01CA222124-01A1
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2019
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reese JB, Zimmaro LA, Lepore SJ, Sorice KA, Handorf E, Daly MB, Schover LR, Kashy D, Westbrook K, Porter LS. Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2.
PubMed 32051002
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention
- ClinicalTrials.gov ID
- NCT03930797
- Acronym / sponsor ID
- 18-1025
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes.
Detailed description
Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE).
The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intimacy Enhancement | Experimental | Behavioral: Intimacy EnhancementParticipants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. |
| Living Healthy Together | Active comparator | Behavioral: Living Healthy TogetherParticipants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is female
- Patient age 18 years or older
- Patient has a medically confirmed diagnosis of non-recurrent breast cancer (Stages T1-T4, N0-N1, M0)
- Patient completed active treatment (e.g., chemotherapy, radiation therapy, surgery, immunotherapy) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Patient is currently in a partnered relationship that could involve sexual activity
Key exclusion criteria (8 listed)
- Patient or partner is not able to speak and read English, as stated in medical record, as observed by study team member or in self-report
- Patient or partner ECOG Performance score > 2 OR medically unable to participate as judged by physician/in medical record or by self-report
- Patient or partner has a hearing impairment
- 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 |
|---|---|---|
| Intimacy EnhancementThe IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. | Behavioural | Intimacy Enhancement |
| Living Healthy TogetherThe Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. | Behavioural | Living Healthy Together |
Primary outcome
Change in Self-Reported Patient Sexual Function
Time frame: Baseline up to 6 weeks
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.
10 secondary outcomes
Change in Self-Reported Partner Sexual Function
Time frame: Baseline up to 6 weeks
Change in Self-Reported Patient Sexual Distress
Time frame: Baseline up to 6 weeks
Change in Patients' Self-Reported Relationship Intimacy
Time frame: Baseline up to 6 weeks
Change in Partners' Self-Reported Relationship Intimacy
Time frame: Baseline up to 6 weeks
Change in Patients' Self-Reported Relationship Quality
Time frame: Baseline up to 6 weeks
Change in Partners' Self-Reported Relationship Quality
Time frame: Baseline up to 6 weeks
Change in Patients' Self-Reported Anxiety
Time frame: Baseline up to 6 weeks
Change in Partners' Self-Reported Anxiety
Time frame: Baseline up to 6 weeks
Change in Patients' Self-Reported Depressive Symptoms
Time frame: Baseline up to 6 weeks
Change in Partners' Self-Reported Depressive Symptoms
Time frame: Baseline up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32051002Reese JB, Zimmaro LA, Lepore SJ, Sorice KA, Handorf E, Daly MB, Schover LR, Kashy D, Westbrook K, Porter LS. Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2.
- 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 Intimacy Enhancement and Living Healthy Together in people with 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 8 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: finished, as of the sponsor's last update on 11 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930797, which also lists 1 linked publication.
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 11 Jul 2024.