Evidence map›Paper›PMID 39023547›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2024

A sequential multiple assignment randomized trial of symptom management for cancer survivors during treatment and their informal caregivers.

Terry Badger, Chris Segrin, Tracy E Crane, Pavani Chalasani, Waqas Arslan, Mary Hadeed, Charles W Given, Alla Sikorskii

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03743415 (Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03743415 nacompletednot on this map

Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use

TypeinterventionalSponsorUniversity of ArizonaRan2019 to 2022Enrolled908ConditionsCancerArmsHandbook, TIP-C plus Handbook
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Terry BadgerCollege of Nursing, University of Arizona, 1305 N. Martin Avenue, Tucson, AZ, 85721, USA. tbadger@arizona.edu.ORCID http://orcid.org/0000-0002-2403-9562
Chris SegrinDepartment of Communication, University of Arizona, Tucson, AZ, 85721, USA.
Tracy E CraneDivision of Medical Oncology, Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, FL, USA.
Pavani ChalasaniDivision of Hematology-Oncology, George Washington University, Washington, DC, USA.
Waqas ArslanCollege of Medicine, University of Arizona, Phoenix, AZ, USA.
Mary HadeedCollege of Nursing, University of Arizona, 1305 N. Martin Avenue, Tucson, AZ, 85721, USA.
Charles W GivenCollege of Nursing, Michigan State University, East Lansing, MI, USA.
Alla SikorskiiDepartment of Psychiatry, College of Osteopathic Medicine, Michigan State University, East Lansing, MI, USA.

Funding

Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care UseR01CA224282 · NCI · UNIVERSITY OF ARIZONA · PI BADGER, TERRY A · 2018 to 2021
$2.7M
NCI NIH HHS R01 CA224282
6 · The paper itself

Abstract

contextMany cancer survivors and their informal caregivers experience multiple symptoms during the survivor's treatment.

objectiveTest relative effectiveness and optimal sequencing of two evidence-based interventions for symptom management.

methodsIn this sequential multiple assignment randomized trial (SMART), survivors of solid tumors with elevated depression or anxiety and their caregivers as dyads were initially randomized after baseline assessment in a 3:1 ratio to the Symptom Management and Survivorship Handbook (SMSH, N = 277 dyads) intervention or SMSH plus 8 weeks of telephone interpersonal counseling (TIPC, N = 97 dyads). After 4 weeks, survivors who were not responding (no improvement or worsening score on depression and/or anxiety item) to SMSH only and their caregivers were re-randomized to continue with SMSH alone (N = 44 dyads) to give it more time or to SMSH + TIPC (N = 44 dyads). Mixed effects and generalized linear models compared severity of depression, anxiety, and a summed index of 16 other symptoms over weeks 1-13 and week 17 between randomized groups and among three dynamic treatment regimes (DTRs). Dyads received SMSH only for 12 weeks (DTR1); SMSH for 12 weeks with 8 weeks of TIPC added from week 1 (DTR2); and SMSH for 4 weeks followed by the combined SMSH + TIPC for 8 weeks if no response at 4 weeks (DTR3).

resultsSurvivors randomized initially to SMSH alone had significantly lower anxiety over weeks 1-13 compared to those randomized to the combined SMSH + TIPC. In comparing DTRs, survivor's anxiety was significantly lower at week 13 for DTR1 compared to DTR2 with no other main effects for survivors or caregivers. Exploratory moderation analyses indicated a potential benefit of adding TIPC for caregivers of non-responders with elevated baseline symptoms.

conclusionSMSH + TIPC did not result in better symptom outcomes at week 17 than SMSH alone. Lower intensity SMSH may improve depression and anxiety symptoms for most survivors and their caregivers.

trial registrationClinicaltrails.gov ID number, NCT03743415; approved and posted on 11/16/2018.

Indexed as

AnxietyCancer SurvivorsCaregiversDepressionAdultAgedCounselingFemaleHumansMaleMiddle AgedNeoplasmsAnxietyDepressionInterpersonal counselingSequential multiple assignment randomized trialSurvivors and caregiversSymptom management

Identifiers

PMID39023547

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.