Evidence map›Paper›PMID 38336739›Full record

ArticleTrials2024

Effectiveness of structured psycho-oncological counseling for relatives of lung cancer patients based on the CALM approach-study protocol of a randomized controlled trial.

Julia Dusel, Karin Meng, Hanna Arnold, Antonia Rabe, Elisabeth Jentschke

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
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

5 authors at 1 institution in 1 country.

Julia DuselUniversity Hospital Würzburg, Comprehensive Cancer Center Mainfranken, Josef-Schneider Str. 6, Würzburg, D-97080, Germany.
Karin MengUniversity Hospital Würzburg, Comprehensive Cancer Center Mainfranken, Josef-Schneider Str. 6, Würzburg, D-97080, Germany.
Hanna ArnoldUniversity Hospital Würzburg, Comprehensive Cancer Center Mainfranken, Josef-Schneider Str. 6, Würzburg, D-97080, Germany.
Antonia RabeUniversity Hospital Würzburg, Comprehensive Cancer Center Mainfranken, Josef-Schneider Str. 6, Würzburg, D-97080, Germany.
Elisabeth JentschkeUniversity Hospital Würzburg, Comprehensive Cancer Center Mainfranken, Josef-Schneider Str. 6, Würzburg, D-97080, Germany. Jentschke_E@ukw.de.ORCID http://orcid.org/0000-0001-8532-559X
Comprehensive Cancer Center Mainfranken · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe high incidence combined with the high lethality and bad prognosis of lung cancer highlight the need for psycho-oncological care for both patients and their relatives. While psychological interventions for relatives might be helpful, further research on the impact of specific interventions is necessary. Therefore, this trial aims to evaluate structured psycho-oncological counseling for relatives of lung cancer patients based on the Managing Cancer And Living Meaningfully (CALM) approach compared to usual care. In addition, we explore the impact of psycho-oncological support of relatives on the patients' mental health outcomes.

methodsThe study is a single-center, prospective, randomized controlled trial with two measurement time points. Relatives of lung cancer patients and, thus, the patients themselves (i.e., dyads) are randomly allocated to the intervention group (IG) or the control group (CG) regardless of their disease or treatment stage. Relatives in the IG receive structured counseling based on the CALM approach (three to six sessions with psycho-oncologists). The CG receives usual psycho-oncological care. In addition, cancer patients in both study arms can request psycho-oncological support (usual care) as needed, but they will not get a specific intervention. Relatives and patients complete assessments at baseline (T0) and after the intervention/6 weeks (T1). The primary outcome for relatives is anxiety. Relatives' secondary outcomes include depressive symptoms, distress, supportive care needs, and quality of life. Patients' outcomes include anxiety, depression, and distress. All outcomes are assessed using self-report validated questionnaires. Intervention effects will be evaluated using analysis of covariance (ANCOVA) adjusting for baseline values. Power calculations reveal the need to enroll 200 subjects to detect an effect of d = 0.4. DISCUSSION: The study will provide evidence for the effectiveness of the CALM intervention in relatives of lung cancer patients. Furthermore, study results will contribute to a better understanding of the effectiveness of a psycho-oncological intervention for highly impaired cancer patients and their relatives. If the CALM intervention positively affects the relatives' psychosocial outcome, it may be implemented in routine care.

trial registrationGerman Clinical Trials Register DRKS00030077. Retrospectively registered on 26 October 2022.

Indexed as

Lung NeoplasmsNeoplasmsCounselingHumansMental HealthProspective StudiesQuality of LifeRandomized Controlled Trials as TopicCALMCounselingFamily careLung cancerOncologyPsycho-oncology

Identifiers

PMID38336739
PMCPMC10858519
OpenAlexW4391722605

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.