Trial Outcomes & Findings for How Easy-to-Follow Exercises Can Help Cancer Patients With Anxiety While Receiving Chemotherapy (NCT NCT06943638)

Results Overview

The STAI-State (Greek version, State-Trait Anxiety Inventory -STAI-) will be used to assess anxiety levels in cancer patients undergoing chemotherapy, before and after a brief exercise intervention. The STAI-State scale has a 20-item questionnaire where individuals rate how they feel at a particular moment on a scale from "not at all" to "very much so." "Not at all" equal to 1, "Somewhat" to 2, "Moderately so" to 3, "Very much so" to 4. Scores are submitted and range from 20 to 80, with higher scores indicating greater anxiety. No subscale is required to compute At baseline (Time = 0 minutes), participants complete the STAI-State scale. They then engage in a 15-minute mild exercise and stretching program tailored to their physical condition. In some cases, particularly among younger participants, the session may be conducted in small groups of up to 2 individuals. Immediately post-intervention (approximately 20 minutes from baseline), participants complete the STAI-State scale again.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Baseline and approximately 20 minutes post-intervention

Results posted on

2025-08-01

Participant Flow

Participants were recruited from the General Oncology Hospital of Kifissia "Agioi Anargyroi" in Athens, Greece. Eligible patients undergoing chemotherapy were invited to participate during routine clinical visits. Written informed consent was obtained from all participants.

There are no pre-assignement details

Participant milestones

Participant milestones
Measure	Mild Exercise and Stretching They received individualized workout and stretching programme to relieve some of the stress
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild Exercise and Stretching n=45 Participants They received individualized workout and stretching programme to relieve some of the stress
Age, Continuous	68.5 Years STANDARD_DEVIATION 8.5 • n=45 Participants
Sex: Female, Male Female	20 Participants n=45 Participants
Sex: Female, Male Male	25 Participants n=45 Participants
Region of Enrollment Greece	45 Participants n=45 Participants

PRIMARY outcome

Timeframe: Baseline and approximately 20 minutes post-intervention

The STAI-State (Greek version, State-Trait Anxiety Inventory -STAI-) will be used to assess anxiety levels in cancer patients undergoing chemotherapy, before and after a brief exercise intervention. The STAI-State scale has a 20-item questionnaire where individuals rate how they feel at a particular moment on a scale from "not at all" to "very much so." "Not at all" equal to 1, "Somewhat" to 2, "Moderately so" to 3, "Very much so" to 4. Scores are submitted and range from 20 to 80, with higher scores indicating greater anxiety. No subscale is required to compute At baseline (Time = 0 minutes), participants complete the STAI-State scale. They then engage in a 15-minute mild exercise and stretching program tailored to their physical condition. In some cases, particularly among younger participants, the session may be conducted in small groups of up to 2 individuals. Immediately post-intervention (approximately 20 minutes from baseline), participants complete the STAI-State scale again.

Outcome measures

Outcome measures
Measure	Mild Exercise and Stretching n=45 Participants They received individualized workout and stretching programme to relieve some of the stress
The Change in the Anxiety Assessment Scale (STAI-State) for Cancer Patients Receiving Chemotherapy Doing Mild Exercises and Stretches Pre- intervention	37.73 STAI-State score Standard Deviation 13.33
The Change in the Anxiety Assessment Scale (STAI-State) for Cancer Patients Receiving Chemotherapy Doing Mild Exercises and Stretches Post- intervention	32 STAI-State score Standard Deviation 14.22

Adverse Events

Mild Exercise and Stretching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Mavrogiannopoulou, Physiotherapist and Study coordinator

General Oncology Hospital of Kifissia "Agioi Anargyroi"

Phone: +30 6941464095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place