Trial Outcomes & Findings for A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer (NCT NCT04802720)
NCT ID: NCT04802720
Last Updated: 2026-06-10
Results Overview
as assessed via the HADS Developed by Zigmond and Snaith in 1983, the HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Items of the overall severity of anxiety and depression are rated on a five-point (0-4) severity scales (ranging from 0 = no not at all, to 4 = yes definitely), for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
348 participants
Primary outcome timeframe
up to 6 months
Results posted on
2026-06-10
Participant Flow
Participant milestones
| Measure |
ERT-C: Emotion Regulation Therapy for Cancer Caregivers
Emotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers
Cognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
2. coping effectiveness training (Session 2);
3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
4. challenging and restructuring unhelpful cognitions (Session 4);
5. behavioral activation within the limitations of the caregiving context (Session 5);
6. problem-solving (Session 6);
7. communication strategies and assertiveness training (Session 7);
8. consolidating gains, maintenance, and relapse prevention (Session 8).
|
Training Case Group
Will be assigned to receive ERT-C only and will not complete questionnaires.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
Patient Group
Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
124
|
120
|
0
|
95
|
|
Overall Study
COMPLETED
|
73
|
79
|
0
|
48
|
|
Overall Study
NOT COMPLETED
|
51
|
41
|
0
|
47
|
Reasons for withdrawal
| Measure |
ERT-C: Emotion Regulation Therapy for Cancer Caregivers
Emotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers
Cognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
2. coping effectiveness training (Session 2);
3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
4. challenging and restructuring unhelpful cognitions (Session 4);
5. behavioral activation within the limitations of the caregiving context (Session 5);
6. problem-solving (Session 6);
7. communication strategies and assertiveness training (Session 7);
8. consolidating gains, maintenance, and relapse prevention (Session 8).
|
Training Case Group
Will be assigned to receive ERT-C only and will not complete questionnaires.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
Patient Group
Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
22
|
0
|
30
|
|
Overall Study
Withdrawal by Subject
|
24
|
16
|
0
|
4
|
|
Overall Study
Caregiver became bereaved during study period
|
6
|
3
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
13
|
Baseline Characteristics
A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer
Baseline characteristics by cohort
| Measure |
ERT-C: Emotion Regulation Therapy for Cancer Caregivers
n=124 Participants
Emotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers
n=120 Participants
Cognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
2. coping effectiveness training (Session 2);
3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
4. challenging and restructuring unhelpful cognitions (Session 4);
5. behavioral activation within the limitations of the caregiving context (Session 5);
6. problem-solving (Session 6);
7. communication strategies and assertiveness training (Session 7);
8. consolidating gains, maintenance, and relapse prevention (Session 8).
|
Training Case Group
Will be assigned to receive ERT-C only and will not complete questionnaires.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
Patient Group
n=95 Participants
Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
—
|
4 Participants
n=265 Participants
|
17 Participants
n=568 Participants
|
|
Age, Continuous
|
53.6 years
n=9 Participants
|
51.1 years
n=27 Participants
|
—
|
56.6 years
n=265 Participants
|
53.6 years
n=568 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=9 Participants
|
84 Participants
n=27 Participants
|
—
|
46 Participants
n=265 Participants
|
222 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=9 Participants
|
36 Participants
n=27 Participants
|
—
|
49 Participants
n=265 Participants
|
117 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
—
|
6 Participants
n=265 Participants
|
22 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=9 Participants
|
108 Participants
n=27 Participants
|
—
|
88 Participants
n=265 Participants
|
311 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
—
|
1 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
—
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
—
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
—
|
3 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=9 Participants
|
98 Participants
n=27 Participants
|
—
|
85 Participants
n=265 Participants
|
287 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
—
|
0 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
—
|
3 Participants
n=265 Participants
|
16 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
124 Participants
n=9 Participants
|
120 Participants
n=27 Participants
|
—
|
95 Participants
n=265 Participants
|
339 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: no participants accrued to Training case group. Patient group not assessed at 6 months
as assessed via the HADS Developed by Zigmond and Snaith in 1983, the HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Items of the overall severity of anxiety and depression are rated on a five-point (0-4) severity scales (ranging from 0 = no not at all, to 4 = yes definitely), for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress
Outcome measures
| Measure |
ERT-C: Emotion Regulation Therapy for Cancer Caregivers
n=82 Participants
Emotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers
n=98 Participants
Cognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
2. coping effectiveness training (Session 2);
3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
4. challenging and restructuring unhelpful cognitions (Session 4);
5. behavioral activation within the limitations of the caregiving context (Session 5);
6. problem-solving (Session 6);
7. communication strategies and assertiveness training (Session 7);
8. consolidating gains, maintenance, and relapse prevention (Session 8).
|
Training Case Group
Will be assigned to receive ERT-C only and will not complete questionnaires.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
Patient Group
Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C
|
|---|---|---|---|---|
|
Changes in Anxiety Symptoms
|
-3.42 score on a scale
Standard Error 0.4
|
-3.45 score on a scale
Standard Error 0.4
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: no participants accrued to Training case group. Patient group not assessed at 6 months
as assessed via the HADS Developed by Zigmond and Snaith in 1983, the HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Items of the overall severity of anxiety and depression are rated on a five-point (0-4) severity scales (ranging from 0 = no not at all, to 4 = yes definitely), for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress
Outcome measures
| Measure |
ERT-C: Emotion Regulation Therapy for Cancer Caregivers
n=82 Participants
Emotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers
n=98 Participants
Cognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
2. coping effectiveness training (Session 2);
3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
4. challenging and restructuring unhelpful cognitions (Session 4);
5. behavioral activation within the limitations of the caregiving context (Session 5);
6. problem-solving (Session 6);
7. communication strategies and assertiveness training (Session 7);
8. consolidating gains, maintenance, and relapse prevention (Session 8).
|
Training Case Group
Will be assigned to receive ERT-C only and will not complete questionnaires.
Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).
|
Patient Group
Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C
|
|---|---|---|---|---|
|
Changes in Depressive Symptoms
|
-1.80 score on a scale
Standard Error 0.4
|
-1.68 score on a scale
Standard Error 0.4
|
—
|
—
|
Adverse Events
ERT-C: Emotion Regulation Therapy for Cancer Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Training Case Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 13 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca Saracino PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-0263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place