Breast CancerNCT02721147
Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
A study testing Intimacy Enhancing Intervention, Living Healthy Together and Partner-Assisted Coping Skills Training in people with Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intimacy Enhancing Intervention, Living Healthy Together and Partner-Assisted Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2015to 29 Sep 2017
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
- Lives with a romantic partner > 6 months
- Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- No hearing impairment in patient or partner
Who cannot join
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
- Conditions
- Breast Cancer
- Being tested
- Intimacy Enhancing Intervention, Living Healthy Together, Partner-Assisted Coping Skills Training, Behavioral, Psychological or Informational Intervention
- 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 Enhancing InterventionBehavioural
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
Living Healthy TogetherBehavioural
Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
Partner-Assisted Coping Skills TrainingBehavioural
Receive couple-based intimacy enhancement intervention
Behavioral, Psychological or Informational InterventionBehavioural
Receive educational information and support
| Study group | Role | What they receive |
|---|---|---|
| Intimacy Enhancing Intervention | Experimental | Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home. Receives: Behavioral: Intimacy Enhancing Intervention; Behavioral: Partner-Assisted Coping Skills Training |
| Living Healthy Together | Active comparator | Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials. Receives: Behavioral: Living Healthy Together; Behavioral: Behavioral, Psychological or Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Treatment as Measured Through Study Accrual
Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
Measured: Up to 8 weeks
Feasibility of the Treatment as Measured Through Study Attrition
Feasibility of treatment is measured through the number of randomized participants who completed the study.
Measured: Up to 8 weeks
Feasibility of the Treatment as Measured Through Session Completion by Participant
Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
Measured: Up to 8 weeks
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
Acceptability was measured through the median score on a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate higher satisfaction with the service (acceptability). A median score of 28 or higher is considered acceptable. This measure was collected for both patients and partners.
Measured: Up to 8 weeks
Secondary outcomes (12)
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Total scale scores range from 2 to 36. Higher scores indicate higher level of functioning. Change in mean patient FSFI score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Sexual Function Measured Using the International Index of Erectile Function
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 from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10. Higher T-scores indicate higher levels of sexual satisfaction. Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported. Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Beliefs (Self-efficacy)
Total scale scores range from 0 to 100. Higher scores indicate higher degree of self-efficacy for coping with sexual concerns. Change in mean self-efficacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner. Change in mean emotional intimacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
Total scale scores range from 13 to 78. Higher scores indicate more communication. Change in mean sexual communication score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Body Image Distress Measured Using the Body Image Scale
Total scale scores range from 0 to 30. Higher scores indicate higher level of body image distress. Change in mean body image distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Depression Measured Using the Patient Health Questionnaire-9 Item
Total scale scores range from 0 to 27. Higher scores indicate higher level of depression. Change in mean depression score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in depression from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Change in Cancer-related Distress Using the Impact of Events Scale-Revised
Total scale scores range from 0 to 88. Higher scores indicate higher levels of distress. Change in mean cancer-related distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in distress from pre- to post-intervention.
Measured: Baseline to up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start27 Oct 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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.
- Other trials for 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
- None (open label)
- Enrolment
- 89 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
- NCT02721147
- Sponsor's protocol ID
- 15-8007
- Other IDs
- 1R21CA191354-01
- Status last verified
- Oct 2018
- First submitted
- 14 Mar 2016
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
- ClinicalTrials.gov ID
- NCT02721147
- Acronym / sponsor ID
- 15-8007
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Posted 25 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intimacy Enhancing Intervention | Experimental | Behavioral: Intimacy Enhancing Intervention, Behavioral: Partner-Assisted Coping Skills TrainingParticipants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home. |
| Living Healthy Together | Active comparator | Behavioral: Living Healthy Together, Behavioral: Behavioral, Psychological or Informational InterventionParticipants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
Key exclusion criteria (6 listed)
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
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 Enhancing InterventionParticipants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home. | Behavioural | Intimacy Enhancing Intervention |
| Living Healthy TogetherParticipants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials. | Behavioural | Living Healthy Together |
| Partner-Assisted Coping Skills TrainingReceive couple-based intimacy enhancement intervention | Behavioural | Intimacy Enhancing Intervention |
| Behavioral, Psychological or Informational InterventionReceive educational information and support | Behavioural | Living Healthy Together |
Primary outcome
Feasibility of the Treatment as Measured Through Study Accrual
Time frame: Up to 8 weeks
Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
Feasibility of the Treatment as Measured Through Study Attrition
Time frame: Up to 8 weeks
Feasibility of treatment is measured through the number of randomized participants who completed the study.
Feasibility of the Treatment as Measured Through Session Completion by Participant
Time frame: Up to 8 weeks
Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Up to 8 weeks
Acceptability was measured through the median score on a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate higher satisfaction with the service (acceptability). A median score of 28 or higher is considered acceptable. This measure was collected for both patients and partners.
12 secondary outcomes
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Time frame: Baseline to up to 8 weeks
Change in Sexual Function Measured Using the International Index of Erectile Function
Time frame: Baseline to up to 8 weeks
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
Time frame: Baseline to up to 8 weeks
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
Time frame: Baseline to up to 8 weeks
Change in Beliefs (Self-efficacy)
Time frame: Baseline to up to 8 weeks
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
Time frame: Baseline to up to 8 weeks
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
Time frame: Baseline to up to 8 weeks
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
Time frame: Baseline to up to 8 weeks
Change in Body Image Distress Measured Using the Body Image Scale
Time frame: Baseline to up to 8 weeks
Change in Depression Measured Using the Patient Health Questionnaire-9 Item
Time frame: Baseline to up to 8 weeks
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
Time frame: Baseline to up to 8 weeks
Change in Cancer-related Distress Using the Impact of Events Scale-Revised
Time frame: Baseline to up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Enhancing Intervention, Living Healthy Together and Partner-Assisted Coping Skills Training 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 6 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 25 Oct 2018. 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 25 Oct 2018). 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?
Feasibility of the Treatment as Measured Through Study Accrual (time frame: Up to 8 weeks). The study lists 4 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 25 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.