Evidence map›Paper›PMID 25351456›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2015

Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.

John M Salsman, Jennifer L Beaumont, Katy Wortman, Ying Yan, John Friend, David Cella

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01387282 (Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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.

NCT01387282 phase3completednot on this map

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

TypeinterventionalSponsorHelsinn Therapeutics (U.S.), IncRan2011 to 2015Enrolled495ConditionsCachexia, Non-Small Cell Lung CancerArmsAnamorelin HCl, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Measuring health-related quality of life in patients with advanced cancer: a systematic review of self-administered measurement instruments.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Impact ofCurrent therapeutic research, clinical and experimental · 2020
    Article
  9. Quality of life and anorexia/cachexia in lung cancer: validation of the Spanish version of the FAACT instrument.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018
    Article
  10. Article
  11. Article
  12. Validation of the Chinese version of functional assessment of anorexia-cachexia therapy (FAACT) scale for measuring quality of life in cancer patients with cachexia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Article
  13. Review
  14. Systematic content evaluation and review of measurement properties of questionnaires for measuring self-reported fatigue among older people.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2015
    Article
  15. 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

6 authors.

John M SalsmanDepartment of Medical Social Sciences, Feinberg School of Medicine at Northwestern University, 633 North St. Clair, 19th Floor, Chicago, IL, 60611, USA, j-salsman@northwestern.edu.
Jennifer L Beaumont
Katy Wortman
Ying Yan
John Friend
David Cella

Funding

Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Daniela E Matei · 1993 to 2026
$153.9M
NCI NIH HHS P30 CA060553
6 · The paper itself

Abstract

purposeCancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 (NCT01387282) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).

methodsIn the ROMANA 2 trial, 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 203 patients who reached the week 12 visit at the time of data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12.

resultsTwo 4-item scales (fatigue/activity and appetite/eating) from the FACIT-F and FAACT questionnaires, respectively, demonstrated good internal consistency reliability, validity, and responsiveness (also referred to as the Simplified Evaluation of Fatigue (SEF) and Simplified Evaluation of Appetite (SEA), respectively). The estimated important difference for each scale was 1-2 points.

conclusionsThese brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine the clinical utility of these scales and their impact on treatment decision-making.

Indexed as

Health Status IndicatorsAdultAgedAged, 80 and overAnorexiaAppetiteAppetite StimulantsCachexiaCarcinoma, Non-Small-Cell LungFatigueFemaleHand StrengthHumansHydrazinesLung NeoplasmsMaleanamorelinAppetite StimulantsHydrazinesOligopeptidesPlacebosReceptors, Ghrelin

Identifiers

PMID25351456
PMCPMC4376952

What OpenQuestion holds

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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.