Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03743415 |
| Other study ID # |
1804501501 |
| Secondary ID |
R01CA224282 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 16, 2019 |
| Est. completion date |
May 27, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
University of Arizona |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new
diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety
and their informal caregivers. Design: The investigators selected the SMART design for this
study over alternative designs (e.g.,implementation designs) because the SMART design allows
a precision or personalized approach to determine the right treatment at the right dose with
the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show
promise in developing the sequences of evidence-based interventions for more efficient and
individualized patient- and caregiver-centered care. The investigators will use findings from
this study to create an algorithm for clinically meaningful decision making about symptom
management for survivors and their caregivers to be tested in future
implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned
to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone
Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone
for 4 weeks. During 12 weeks following initial randomization, all participants will receive
weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess
its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the
survivor's response to the intervention will be determined. If the survivor responds (defined
as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook
alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a
worsening score for depression and/or anxiety), the dyad will be re-randomized to either
continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be
assessed at baseline, weeks 13 and 17 for both members of the dyad.
Description:
Informal caregivers, typically family members or friends, provide more than half of the care
needed for the 5.7 million cancer survivors (defined as individuals from diagnosis to
end-of-life) in the United States, often with negative consequences to their health.
Caregivers assist with the management of the survivor's symptoms such as fatigue, pain and
insomnia, and others.Psychological distress (depression and anxiety) has been reported in at
least 30% of survivors and their caregivers who are not always prepared for the task of
symptom management. This research assists both the caregiver and survivor (the dyad in this
study) to manage the survivor's cancer- and treatment-related symptoms and the distress of
both members of the dyad in a sample of 298 survivors with elevated depression or anxiety and
their 298 caregivers. Dyads will be recruited during the survivor's chemotherapy or targeted
therapy for a solid tumor, a time when symptom burden and psychological distress are
particularly high.
The investigators will use two evidence-based interventions extensively tested against active
and passive controls in traditional randomized controlled trials (RCTs). While overall
efficacy of these interventions has been established, individuals differ in their responses.
When an intervention does not initially work, clinical logic is to either extend the
timeframe or prescribe a different intervention. Yet, these alternatives are seldom tested
and not evidence-based. The proposed project advances beyond a traditional RCT of testing
fixed "one size fits all" interventions to the sequential multiple assignment randomized
trial (SMART) design to build the evidence base for intervention sequencing that accounts for
heterogeneity of responses.
The first intervention, a printed symptom management and survivorship handbook (Handbook)
with strategies for self-management of symptoms common during chemotherapy will be given to
both survivor and caregiver (the dyad). Handbook strategies, if successfully enacted, produce
positive symptom responses for the survivor. However, psychological distress of the survivor
or the caregiver may diminish the receipt and enactment of the Handbook strategies and also
exacerbate the severity of other symptoms which, in turn, produces poor symptom responses.
Research by this team has documented dyadic effects where survivors' psychosocial distress
impacts that of the caregiver and vice versa. The survivor's and caregiver's distress exhibit
similar trajectories. Therefore, the second intervention tested in sequencing is the 8-week
telephone interpersonal counseling intervention (TIP-C) to manage psychological distress of
the dyad.
The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and
Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C)
+Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks
following initial randomization, all participants will receive weekly telephone contacts to
assess symptoms, deliver the assigned intervention and assess its enactment and fidelity.
After the initial 4 weeks in the Handbook alone group, the survivor's response to the
intervention will be determined. If the survivor responds (defined as a reduced score on
depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks.
If the survivor is a non-responder (defined as no improvement or a worsening score for
depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook
alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks
13 and 17 for both members of the dyad.
The following specific aims will be tested.
1. Determine if dyads in the TIP-C+Handbook as compared to the Handbook alone group created
by the first randomization will have: a) lower depression, anxiety, and summed severity
of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of
healthcare services (hospitalizations, urgent care or emergency department [ED] visits)
during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and
lower caregiver burden during weeks 13 and 17 (potential mediators).
2. Among non-responders to the Handbook alone after 4 weeks, determine if dyads in
TIP-C+Handbook as compared to the Handbook alone group created by the second
randomization will have better primary and secondary outcomes and potential mediators at
weeks 5-12, 13, and 17.
3. Test the interdependence in survivors' and caregivers' primary and secondary outcomes.
4. Determine which characteristics of the dyad are associated with responses to the
Handbook alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13
and 17 so as to determine tailoring variables for the decision rules of individualized
sequencing of interventions in the future.
