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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34CA286710 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns.
The main study aims are to:
Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial.
Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program.
Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey.
All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | ||
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful After Cancer Program | Behavioral | The Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Accrual Rate- The percent of eligible candidates who enroll | Baseline | |
| Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist. | Adherence to the manual is assessed by independent review of audio-recorded intervention sessions using a checklist of material to be covered in each session. | Up to 1 week post-intervention. |
| Retention Rate - The percent of enrolled participants who complete all study surveys | Up to the 3 month post-intervention survey at week 22. |
| Measure | Description | Time Frame |
|---|---|---|
| MAC intervention Drop Out- As measured by session attendance. | Percentage of enrolled participants who stop attending the MAC intervention arm after attending the first session. | Up to completion of the 8-week MAC intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome: Interest in sexual activity as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare sexual interest longitudinally after enrollment between those receiving MAC and those receiving usual care. The sexual interest domain has 2 items, Range 2-10. Higher score indicates more interest in sexual activity. | Up to the 3 month post-intervention survey at week 22. |
Inclusion Criteria:
Exclusion Criteria:
• Those who do not comprehend English since the MAC program is only available in English.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Gorman, PhD | Contact | 541-737-2323 | Jessica.Gorman@oregonstate.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samaritan Pastega Regional Cancer Center | Recruiting | Corvallis | Oregon | 97330 | United States |
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| Exploratory Outcome: Body Appreciation as measured by the Body Appreciation Scale. | To compare body appreciation longitudinally after enrollment between those receiving MAC and those receiving usual care. The Body Appreciation Scale has13 items, Range 13-65. Higher score indicates more positive body appreciation. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory Outcome: Sexual Satisfaction as measured by the Global Measure of Sexual Satisfaction scale (GMSEX). | To compare sexual satisfaction longitudinally after enrollment between those receiving MAC and those receiving usual care. The GMSEX scale has 5 items, Range 5-35. Higher score indicates higher level of sexual satisfaction. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Self-Efficacy as measured by the Self-Efficacy for Managing Chronic Disease Scale (adapted). | To compare self-efficacy for managing sexual health in chronic disease longitudinally after enrollment between those receiving MAC and those receiving usual care. The adapted self-efficacy for managing chronic disease scale has 6 items, Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Self-compassion as measured by the Self-Compassion Scale Short Form (SCS-SF). | To compare self-compassion longitudinally after enrollment between those receiving MAC and those receiving usual care. The SCS-SF has 12 items, Range 12-60. Higher score indicates greater self-compassion for managing chronic disease scale has 6 items, Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Mindfulness as measured by the Five-Facet Mindfulness Questionnaire (FFMQ-15). | To compare mindfulness longitudinally after enrollment between those receiving MAC and those receiving usual care. The FFMQ-15 has 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. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Social support as measured by the modified Medical Outcomes Study Social Support Survey (mMOS-SS). | To compare social support longitudinally after enrollment between those receiving MAC and those receiving usual care. The mMOS-SS has 8 items, Range 1-5. The score for mMOS-SS is calculated as the average score of subscale items transformed to a zero to 100 scale, with higher scores indicating more support. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Depressive Symptoms as measured by the Patient Health Questionnaire (PHQ-8) | To compare depressive symptoms longitudinally after enrollment between those receiving MAC and those receiving usual care. The PHQ-8 has 8 items, Range 0-24. Higher scores indicate higher levels of depressive symptoms. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Anxiety as measured by the PROMIS Emotional Distress Anxiety Short Form 6a. | To compare anxiety longitudinally after enrollment between those receiving MAC and those receiving usual care. The PROMIS Emotional Distress Anxiety Short Form 6a has 6 items, Range 6-30. Higher scores indicate higher levels of anxiety. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Quality of life as measured by the PROMIS Global Health 10. | To compare quality of life longitudinally after enrollment between those receiving MAC and those receiving usual care. The PROMIS Global Health 10 has 10 items, Range 10-50. Higher scores indicate better functioning. | Up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Sexual function (Lubrication) as measured by the lubrication domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare vaginal lubrication longitudinally after enrollment between those receiving MAC and those receiving usual care. The vaginal lubrication domain has 3 items, Range 3-15. Higher score indicates more vaginal lubrication. | From Baseline up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Sexual function (Vaginal Discomfort) as measured by the vaginal discomfort domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare vaginal discomfort longitudinally after enrollment between those receiving MAC and those receiving usual care. The vaginal discomfort domain has 2 items, Range 2-10. Higher score indicates more vaginal discomfort. | From Baseline up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Sexual function (Labia Discomfort) as measured by the labia discomfort domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare labia discomfort longitudinally after enrollment between those receiving MAC and those receiving usual care. The labia discomfort domain has 2 items, Range 2-10. Higher score indicates more labia discomfort. | From Baseline up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Sexual function (Clitoral Discomfort) as measured by the clitoral discomfort domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare clitoral discomfort longitudinally after enrollment between those receiving MAC and those receiving usual care. The clitoral discomfort domain has 2 items, Range 2-10. Higher score indicates more clitoral discomfort. | From Baseline up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Sexual function (Orgasm ability) as measured by the orgasm ability domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare orgasm ability longitudinally after enrollment between those receiving MAC and those receiving usual care. The orgasm ability domain has 1 item, Range 1-5. Higher score indicates more orgasm ability. | From Baseline up to the 3 month post-intervention survey at week 22. |
| Exploratory outcome: Sexual function (Orgasm pleasure) as measured by the orgasm pleasure domain from the PROMIS Sexual Function and Satisfaction Scale. | To compare orgasm pleasure longitudinally after enrollment between those receiving MAC and those receiving usual care. The orgasm pleasure domain has 2 items, Range 2-10. Higher score indicates more orgasm pleasure. | From Baseline up to the 3 month post-intervention survey at week 22. |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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