Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| OHSU Knight Cancer Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.
The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful After Cancer | Experimental | Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful After Cancer | Behavioral | The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility/ Enrollment in the Study | Percentage of participants enrolled of those eligible | Baseline (T1) |
| Feasibility/ Retention in the Study | Number and percentage of participants completing all assessments | 1 month post-intervention (T2) |
| Feasibility/ Retention in the Intervention | Number and percentage attending at least 6 of 8 sessions | 1 month post-intervention (T2) |
| Acceptability of the Intervention | Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability. | 1 month post-intervention (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Interest in Sexual Activity at 1 Month | PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Satisfaction With Sex Life at 1 Month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Stage 0 (carcinoma in situ)
Female
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jessica R Gorman, PhD, MPH | Oregon State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon State University | Corvallis | Oregon | 97331 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mindful After Cancer | Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. Mindful After Cancer: The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mindful After Cancer | Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. Mindful After Cancer: The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility/ Enrollment in the Study | Percentage of participants enrolled of those eligible | Posted | Number | Percentage enrolled of eligible | Baseline (T1) |
|
|
Duration of study, approximately 3-4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindful After Cancer | Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. Mindful After Cancer: The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Gorman | Oregon State University | 541-737-2323 | Jessica.Gorman@oregonstate.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | May 12, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction. |
| Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Self-efficacy at 1 Month | Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Body Image at 1 Month | Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Body Appreciation at 1 Month | Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Anxiety at 1 Month | PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Depression at 1 Month | Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms | Baseline (T1) and 1 month post-intervention (T2) |
| Change in Facets of Baseline Mindfulness at 1 Month | Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Self-compassion at 1 Month | Self-Compassion Scale short form. 12 items. Total score is calculated based on mean of item responses (each item ranges 1-5). Higher mean score indicates greater self-compassion. | Baseline (T1) and 1 month post-intervention (T2) |
| Change From Baseline Relationship Quality at 1 Month | Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality | Baseline (T1) and 1 month post-intervention (T2) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Health Insurance Coverage | Count of Participants | Participants |
|
| Relationship status | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Self-Reported Cancer Stage | Based on self report only. Higher stage generally indicates a more advanced cancer. | Count of Participants | Participants |
|
| Age at Cancer Diagnosis | Mean | Standard Deviation | years |
|
| Time Since Cancer Diagnosis | Mean | Standard Deviation | years |
|
| Has Biological Child(ren) | Count of Participants | Participants |
|
| Sexually Active | Count of Participants | Participants |
|
| Current Contraception Use | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Feasibility/ Retention in the Study | Number and percentage of participants completing all assessments | Posted | Count of Participants | Participants | 1 month post-intervention (T2) |
|
|
|
| Primary | Feasibility/ Retention in the Intervention | Number and percentage attending at least 6 of 8 sessions | Posted | Count of Participants | Participants | 1 month post-intervention (T2) |
|
|
|
| Primary | Acceptability of the Intervention | Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Interest in Sexual Activity at 1 Month | PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Satisfaction With Sex Life at 1 Month | New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Self-efficacy at 1 Month | Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Body Image at 1 Month | Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Body Appreciation at 1 Month | Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Anxiety at 1 Month | PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Depression at 1 Month | Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change in Facets of Baseline Mindfulness at 1 Month | Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness. | Posted | Mean | Standard Deviation | score on a subscale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Self-compassion at 1 Month | Self-Compassion Scale short form. 12 items. Total score is calculated based on mean of item responses (each item ranges 1-5). Higher mean score indicates greater self-compassion. | Posted | Mean | Standard Deviation | mean score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| Secondary | Change From Baseline Relationship Quality at 1 Month | Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) and 1 month post-intervention (T2) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
|
| Acting with Awareness subscale T2 Mean, SD |
|
| Non-reactivity subscale T1 Mean, SD |
|
| Non-reactivity subscale T2 Mean, SD |
|
| Non-judging subscale T1 Mean, SD |
|
| Non-judging subscale T2 Mean, SD |
|
| Describing subscale T1 Mean, SD |
|
| Describing subscale T2 Mean, SD |
|