Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: symptom management toolkit (SMT): printed symptom management toolkit (SMT) with
strategies for self-management of symptoms common during radiotherapy and/or
chemotherapy will be given t
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for cancer survivor 1. age 18 or older 2. undergoing chemotherapy, hormonal therapy, or targeted therapy for a solid tumor cancer 3. able to perform basic activities of daily living 4. cognitively oriented to time, place, and person (determined by recruiter) 5. reporting severity of more than 2 on depression or more than 4 on anxiety using a 0-10 standardized scale 6. able to speak and understand English or Hindi 7. access to a telephone 8. has a caregiver who can be in any relationship role e.g., spouse, sibling, parent, friend, who can participate with them. for cancer caregiver 1.able to speak and understand English or Spanish 2. access to a telephone 3. not currently receiving counseling and/or psychotherapy 4. not currently treated for cancer
Exclusion criteria
Exclusion criteria: diagnosis of a psychotic disorder in the health record; nursing home resident; bedridden; currently receiving counseling and/or psychotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Symptom Severity Index- Comparison of Two Groups Created by First Randomization at weeks 1-13 and week 17 using the modified General Symptom Distress Scale (GSDS). 2. Symptom Severity Index- Comparison of Two Groups Created by Second Randomization at weeks 5-13 and per week using the modified General Symptom Distress Scale (GSDS). 3. Change in Number and Distress Associated with Caregivers and Survivors Symptoms weekly for 13 weeks and follow-up at 17 weeksTimepoint: 1. 1-13 week, 17 week 2. 5-13 weeks and per week 3. weekly 13 week, 17 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Depressive Symptoms- Comparison of Two Groups Created by First Randomization at week 13 and week 17 using Center for Epidemiological Studies- Depression (CES-D) 20-item scale.Timepoint: 13 week, 17 week;Depressive Symptoms- Comparison of Two Groups Created by Second Randomization at week 13 and week 17 using Center for Epidemiological Studies- Depression (CES-D) 20-item scale.Timepoint: 13 week, 17 week;Anxiety Symptoms- Comparison of Two Groups Created by First Randomization at week 13 and week 17 using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form.Timepoint: 13 week, 17 week;Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization at week 13 and week 17 using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form.Timepoint: 13 week, 17 week;Change in Hospitalizations, provider visits, urgent care or Emergency Department visits at baseline, week 13, 17)Timepoint: 0 week, 13 week, 17 week;Change in Depression and Anxiety of Survivor and Caregiver at baseline, week 13, 17) using Patient Reported Outcomes Information System (PROMIS) depression and anxiety 8 item short form scales.Timepoint: 0 week, 13 week, 17 week;Change in Survivor and Caregiver Self-Efficacy at baseline, week 13, 17) using PROMIS Self-Efficacy for managing symptoms-sf4a.Timepoint: 0 week, 13 week, 17 week;Change in Survivor and Caregiver Social Support at baseline, weeks 13, 17) using PROMIS Informational and Emotional Support-8 item short forms.Timepoint: 0 week, 13 week, 17 week;Change in Caregiver Reactions at baseline, weeks 13, 17 using Caregiver Reaction Assessment Tool.Timepoint: 0 week, 13 week, 17 week | — |
Countries
India
Contacts
Public ContactAbhishek Shankar
All India Institute of Medical Sciences
Outcome results
None listed