Official Title: Caring for Caregivers Increasing Cancer Caregiver Wellbeing and Comforting Sensitivity
Status: COMPLETED
Status Verified Date: 2016-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This randomized clinical trial studies expressive writing in improving the wellbeing or comforting capacity of caregivers of patients with cancer Expressive writing is a type of intervention that asks people to write about important topics in this case participants experience with their spousespartners cancer and their emotionsfeelings surrounding them Expressive writing including benefit finding and traumatic disclosure may be a type of at-home-therapy that caregivers can utilize in an attempt to increase their own wellbeing offer better comfort to cancer patients and by association help cancer patients cope with and manage the cancer experience
Detailed Description: PRIMARY OBJECTIVES
I To test whether one or both types of expressive writing impact spouses of cancer survivors reported emotional wellbeing and reported ability to provide comfort as compared to a control group
OUTLINE Patients are randomized to 1 of 2 arms or assigned to a control arm
ARM I EXPRESSIVE DISCLOSURE Participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks days 2 9 and 16 for a total of 3 sessions Participants write about their emotions pertaining to managing and providing care for the cancer patient
ARM II BENEFIT FINDING Participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks days 2 9 and 16 for a total of 3 sessions Participants write about any benefits that have arisen because of the cancer diagnosis
ARM III CONTROL Participants complete an anonymous 20 minute writing exercise at home on their computer once per week for 2 weeks days 2 9 and 16 for a total of 3 sessions Participants write about an emotionally neutral topic
After completion of study participants are followed up at day 17
Study Oversight
Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID
Type
Domain
Link
NCI-2014-02511
REGISTRY
None
None
9216
OTHER
None
None
P30CA015704
NIH
Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium