Evidence map›Paper›PMID 36271944›Full record

ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2022

Evaluation of supportive care needs, sexuality and quality of life in phase 1 trials: a prospective monocentric study.

Marc Hilmi, Natacha Naoun, Alice Boilève, Arthur Géraud, Arnaud Bayle, Arnaud Pagès, Marion Aupomerol, Matthieu Rouanne, François-Xavier Madec, Fanny Pommeret and 4 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

14 authors at 1 institution in 2 countries.

Marc HilmiDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France. hilmi.marc@gmail.com.ORCID http://orcid.org/0000-0003-4762-6740
Natacha NaounDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Alice BoilèveMedical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Arthur GéraudDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Arnaud BayleDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Arnaud PagèsBiostatistics and Epidemiology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Marion AupomerolMedical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Matthieu RouanneUrology Department, Hopital Foch, Université Paris-Saclay, Suresnes, France.
François-Xavier MadecUrology Department, Hopital Foch, Université Paris-Saclay, Suresnes, France.
Fanny PommeretMedical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Christophe MassardDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Capucine BaldiniDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Florian ScottéInterdisciplinary Patient Pathway Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
Stéphane ChampiatDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Université Paris-Saclay · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatients enrolled in oncology phase 1 trials (ph1) usually have advanced heavily pre-treated cancers with few therapeutic options. Quality of life (QoL) is one of the key cancer-treatment outcome measures, especially in ph1, and sexuality is an important part of Qol but rarely explored. This prospective study aims to assess supportive care needs, QoL and sexuality in ph1.

methodsBetween September 2020 and June 2021, we prospectively recruited patients enrolled in ph1 at Gustave Roussy in France. Supportive care needs, QoL (EORTC QLQ-C30) and sexuality (female sexual function index for women, male sexual health questionnaire [MSHQ] for men) were assessed at baseline, one, three and 5 months. We performed multivariate analyses to identify associations between clinical characteristics, QoL and quality of sexual life over time.

resultsAt baseline, we analyzed 187 patients (45% women (n = 84) and 55% men (n = 103)). Patients expressed the need for consultations in pain management, nutrition, psychology and sexology in 28%, 26%, 19% and 9%, respectively. Lower global QoL was independently associated with Royal Marsden Hospital score (p = 0.012), urogenital location tumor (p = 0.021), elevated CRP levels (p = 0.014) and pain intensity (p = 0.005). Ninety-two percent of women had sexual dysfunction. In men, a lower MSHQ score was independently associated with urogenital location tumor (p = 0.021), ECOG Performance Status (p = 0.006), comorbidity at risk (p = 0.024) and pain intensity (p = 0.004).

conclusionsThere are significant needs for supportive care in ph1, especially in some subgroups of patients. New models of care should be developed to improve early phase pathways.

Indexed as

NeoplasmsQuality of LifeFemaleHumansMaleProspective StudiesSexual BehaviorSexualitySurveys and QuestionnairesOncosexologyPhase 1 trialsQuality of lifeSupportive care

Identifiers

PMID36271944
OpenAlexW4307091444

What OpenQuestion holds

Textmetadata
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.