| Primary | 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). | 182 eligible individuals were approached for the intervention study and were either classified as study refusers or acceptors. | Posted | | Count of Participants | | Participants | | Up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Participants Eligible For Enrollment | Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study. |
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| Primary | Feasibility of the Treatment as Measured Through Study Attrition | Feasibility of treatment is measured through the number of randomized participants who completed the study. | | Posted | | Count of Participants | | Participants | | Up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Educational Control | 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. |
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| Primary | 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. | | Posted | | Count of Participants | | Participants | | Up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Educational Control | 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. |
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| Primary | 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. | 36/40 participants assigned to the IE condition were analyzed (2 participants did not complete sessions and were not given any measures assessing satisfaction with the sessions; 2 participants did not return the post-intervention survey). | Posted | | Median | Standard Deviation | score on a scale | | Up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This outcome is female-specific and was only measured in patients. 19/20 IE patients were analyzed because 1 patient was lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This measure was administered to male partners. 7/9 partners in the educational control arm were analyzed because 1 partner was female and 1 partner had incomplete data at follow-up. 19/20 partners in the IE condition were analyzed because 1 partner did not complete follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to both patients and partners. 38/40 IE participants analyzed because 2 participants were lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to both patients and partners. 38/40 IE participants analyzed because 2 participants were lost to follow-up. 17/18 Educational Control participants were analyzed because 1 participant did not complete the scale at follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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| Secondary | 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. | This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline to up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intimacy Enhancing Intervention | 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/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. | | OG001 | Living Healthy Together | 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. |
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